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临床试验/NCT05944107
NCT05944107已完成4 期

Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
65
试验地点
2
主要终点
Heparin dose

研究概览

简要总结

The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:

  • initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.
  • protamine dose among groups.

Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective procedures
  • cardiac surgery, except for Coronary Artery Bypass Grafting
  • Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

排除标准

  • known allergy to heparin or protamine
  • hematological disease

结局指标

主要结局

Heparin dose

时间窗: Total dose after cardiopulmonary bypass

Heparin dose, IU

Protamine dose

时间窗: Total dose after cardiopulmonary bypass

Protamine dose, mg

次要结局

  • Platelet count(48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Gkiouliava

Principal Investigator

Aristotle University Of Thessaloniki

研究点 (2)

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